title: Informed consent for maternal serum alpha-fetoprotein screening in an inner city population: how informed is it?
abstract: OBJECTIVE
  To determine if women who received information from a provider and viewed a videotape about maternal serum alpha-fetoprotein (MSAFP) screening understood enough to sign informed consent.
  
  
  METHODS
  A prospective qualitative design using tape recorded interviews of women who were provided information regarding MSAFP testing from a provider and from viewing a videotape.
  
  
  METHODS
  Fifty-three inner city pregnant women (58% Hispanic, 39% African-American, 3% white).
  
  
  RESULTS
  Two women answered all questions correctly; no one answered all questions incorrectly. Sixty-two percent correctly answered "What is MSAFP?" Sixteen percent thought "something has to be taken from my belly" for the test. Fifty-nine percent understood that children with spina bifida could have difficulty walking or urinary problems. Seventy-two percent thought their infant would be healthy in all respects if the test was negative. Only 45% could describe the follow-up to a positive test. Eighty percent planned to have the test. Many misconceptions were apparent, and for some knowledge items, as many as 80% of the women answered incorrectly.
  
  
  CONCLUSIONS
  Obtaining truly informed consent for a complex test is not a simple process. Participants met a few, but not all, of the criteria for informed consent. Women understood that the test was voluntary, but their comprehension of the meaning and implication of a positive test results was deficient. Despite this, they signed the informed consent document. The larger question of just how much comprehension is required to consider a woman "informed" has not been answered.
authors.affiliation: Albert Einstein College of Medicine, Department of Obstetrics & Gynecology and Women's Health, Bronx, NY 10461, USA.
authors.forename: M C
authors.initials: MC
authors.lastname: Freda
authors.forename: N
authors.initials: N
authors.lastname: DeVore
authors.forename: N
authors.initials: N
authors.lastname: Valentine-Adams
authors.forename: A
authors.initials: A
authors.lastname: Bombard
authors.forename: I R
authors.initials: IR
authors.lastname: Merkatz
mesh_terms: D032882:Comprehension; D030881:Disclosure; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D008403:Mass Screening / Q000331:legislation & jurisprudence*; D024802:Nurse's Role; D011247:Pregnancy; D037841:Pregnant People; D011446:Prospective Studies; D036301:Qualitative Research; D012106:Research; D014481:United States; D014505:Urban Population; D035862:Vulnerable Populations; D000509:alpha-Fetoproteins
chemical_list: D000509:alpha-Fetoproteins